Dose-Response in Radioimmunotherapy of Lymphoma
- Determine the relationship between estimated absorbed dose and tumor response using
different dosimetric methodologies in patients with non-Hodgkin's lymphoma treated with
iodine I 131 tositumomab or yttrium Y 90 ibritumomab tiuxetan.
- Determine the relationship between estimated absorbed dose and normal organ toxicity
using different dosimetric methodologies in these patients.
- Assess the difference in the dose-response relationship between dosimetric
methodologies in these patients.
- Assess the influence of prior therapy on the dose-response relationship for hematologic
toxicity in these patients.
OUTLINE: Patients are stratified according to planned radioimmunotherapy treatment (iodine I
131 tositumomab vs yttrium Y 90 ibritumomab tiuxetan).
- Stratum 1: Patients receive dosimetric rituximab IV followed by indium In 111 (^111In)
ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo positron emission
tomography (PET)/CT scans and single-photon emission computed tomography (SPECT)/CT
scans between 2-24, 48-72, and 90-120 hours after ^111In ibritumomab tiuxetan
administration. Patients who have acceptable biodistribution receive therapeutic
rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes between
- Stratum 2: Patients receive dosimetric tositumomab IV over 60 minutes followed by
iodine I 131 (^131I) tositumomab IV over 20 minutes on day 0. Patients undergo PET/CT
scans and SPECT/CT scans on days 0; 2, 3 or 4; and 6 or 7. Patients who have acceptable
biodistribution receive therapeutic tositumomab IV over 60 minutes followed by ^131I
tositumomab IV over 20 minutes on approximately day 7.
In both strata, blood is collected at baseline to measure FLT-3 levels. All patients also
undergo a baseline PET/CT scan.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 88 patients will be accrued for this study.
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Relationship between estimated absorbed dose and tumor response using different dosimetric methodologies
July '06 to Sept '10
George Sgouros, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Institutional Review Board
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|